Self-adjusting attachment structure for a cardiac support device

ABSTRACT

A cardiac support device including a jacket and elastic attachment structure for self-securing the jacket to a heart. The attachment structures can include undulating metal and polymer elements, a silicone band and elastomeric filaments on a base end of the jacket.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/368,257, filed Mar. 3, 2006, entitled SELF-ADJUSTING ATTACHMENTSTRUCTURE FOR A CARDIAC SUPPORT DEVICE, which application isincorporated herein by reference in its entirety and for all purposes.

FIELD OF THE INVENTION

The invention relates to devices for providing wall tension relief for adiseased heart. In particular, this invention pertains to such a devicewhich is self-adjusting after placement on the heart.

BACKGROUND OF THE INVENTION

Congestive heart disease is a progressive and debilitating illness. Thedisease is characterized by a progressive enlargement of the heart. Asthe heart enlarges, the heart is performing an increasing amount of workin order to pump blood during each heart beat. In time, the heartbecomes so enlarged that it cannot adequately supply blood. An afflictedpatient is fatigued, unable to perform even simple exerting tasks andexperiences pain and discomfort. Furthermore, as the heart enlarges, theinternal heart valves cannot adequately close. This impairs the functionof the valves and further reduces the heart's ability to supply blood.

Causes of congestive heart disease are not fully known. In certaininstances, congestive heart disease may result from viral infections. Insuch cases, the heart may enlarge to such an extent that the adverseconsequences of heart enlargement continue after the viral infection haspassed and the disease continues its progressively debilitating course.

Patients suffering from congestive heart disease are commonly groupedinto four classes (i.e., Classes I, II, III and IV). In the early stages(e.g., Classes I and II), drug therapy is a commonly proscribedtreatment. Drug therapy treats the symptoms of the disease and may slowthe progression of the disease. However, even with drug therapy, thedisease will typically progress. Furthermore, the drugs sometimes haveadverse side effects.

One relatively permanent treatment for congestive heart disease is hearttransplant. To qualify, a patient must be in the later stages of thedisease (e.g., Classes III and IV with Class IV patients given priorityfor transplant). Such patients are extremely sick individuals. Class IIIpatients have marked physical activity limitations and Class IV patientsare symptomatic even at rest.

Due to the absence of effective intermediate treatment between drugtherapy and heart transplant, Class III and IV patients often sufferbefore qualifying for heart transplant. Furthermore, after thissuffering, the available treatment is often unsatisfactory. Hearttransplant procedures are risky, invasive and relatively expensive, andoften extend a patient's life by only relatively short times. Forexample, prior to transplant, a Class IV patient may have a lifeexpectancy of six months to one-year. Heart transplant can improve theexpectancy to about five years. Unfortunately, not enough hearts areavailable for transplant to meet the needs of congestive heart diseasepatients. In the United States, in excess of 35,000 transplantcandidates compete for only about 2,000 transplants per year. Atransplant waiting list can be about eight to twelve months long onaverage and frequently a patient may have to wait about one to two yearsfor a donor heart. Even if the risks and expense of heart transplantcould be tolerated, this treatment option is becoming increasinglyunavailable. Furthermore, many patients do not qualify for hearttransplant for failure to meet any one of a number of qualifyingcriteria.

Congestive heart failure has an enormous societal impact. In the UnitedStates alone, about five million people suffer from the disease (ClassesI through IV combined). Alarmingly, congestive heart failure is one ofthe most rapidly accelerating diseases (about 550,000 new patients inthe United States each year). Economic costs of the disease have beenestimated at $38 billion annually.

Substantial efforts have been made to find alternative treatments forcongestive heart disease. A surgical procedure referred to as theBatista procedure includes dissecting and removing portions of the heartin order to reduce heart volume. This procedure is the subject of somecontroversy. It is highly invasive, risky and relatively expensive andcommonly includes other relatively expensive procedures (such as aconcurrent heart valve replacement). Also, the treatment is limited toClass IV patients and, accordingly, provides limited hope to patientsfacing ineffective drug treatment prior to Class IV. Furthermore, theconsequences of a failure of this procedure can be severe.

There is, therefore, a need for alternative treatments applicable toeither or both the early and later stages of congestive heart disease toeither stop or slow the progressive nature of the disease.Cardiomyoplasty is a treatment for relatively early stage congestiveheart disease (e.g., as early as Class III dilated cardiomyopathy). Inthis procedure, the latissimus dorsi muscle (taken from the patient'sshoulder) is wrapped around the heart and chronically pacedsynchronously with ventricular systole. Pacing of the muscle results inmuscle contraction to assist the contraction of the heart duringsystole.

While cardiomyoplasty has produced symptomatic improvement, the natureof the improvement is not fully understood. For example, one study hassuggested the benefits of cardiomyoplasty are derived less from activesystolic assist than from remodeling, perhaps because of an externalelastic constraint. The study suggests an elastic constraint (i.e., anon-stimulated muscle wrap or an artificial elastic sock placed aroundthe heart) could provide similar benefits. Kass et al., ReverseRemodeling From Cardiomyoplasty In Human Heart Failure: ExternalConstraint Versus Active Assist, 91 Circulation 2314-2318 (1995).

Even though cardiomyoplasty has demonstrated symptomatic improvement, atleast some studies suggest the procedure only minimally improves cardiacperformance. The procedure is invasive, requiring harvesting a patient'smuscle and an open chest approach (i.e., sternotomy) to access theheart. The procedure is also complicated. For example, it is sometimesdifficult to adequately wrap the muscle around the heart with asatisfactory fit. Also, if adequate blood flow is not maintained to thewrapped muscle, the muscle may necrose. The muscle may stretch afterwrapping, thereby reducing its constraining benefits, and is generallynot susceptible to post-operative adjustment. In addition, the musclemay fibrose and adhere to the heart causing undesirable constraint onthe contraction of the heart during systole.

Mechanical assist devices have been developed as intermediate proceduresfor treating congestive heart disease. Such devices include leftventricular assist devices (“LVAD”) and total artificial hearts (“TAH”).An LVAD includes a mechanical pump for urging blood flow from the leftventricle and into the aorta. An example of a device of this type isshown in the Arnold U.S. Pat. No. 4,995,857. TAH devices, such as theknown Jarvik heart, are used as temporary measures while a patientawaits a donor heart for transplant.

Other cardiac assist devices are disclosed in the Lundback U.S. Pat. No.4,957,477, Grooters U.S. Pat. No. 5,131,905 and Snyders U.S. Pat. No.5,256,132. Both the Grooters and Snyders patents disclose cardiac assistdevices which pump fluid into chambers opposing the heart to assistsystolic contractions of the heart. The Lundbäck patent teaches adouble-walled jacket surrounding the heart. A fluid fills a chamberbetween the walls of the jacket. The inner wall is positioned againstthe heart and is pliable to move with the heart. Movement of the heartduring beating displaces fluid within the jacket chamber.

The commonly assigned Alferness U.S. Pat. No. 5,702,343 discloses acardiac support device, sometimes referred to as a jacket, thatconstrains cardiac expansion to treat congestive heart disease andassociated valvular dysfunction. One embodiment of the jacket is formedof a knit material of polyester having specific compliance and othermaterial characteristics (including elasticity) more fully described inthe Alferness et al. U.S. Pat. No. 6,482,146. Another embodiment of thejacket has a base end with a hem material of double layers as describedin the Nauertz et al. U.S. Pat. No. 6,155,972.

Jackets of the types described in the Alferness et al. U.S. Pat. No.6,482,146 and Nauertz et al. U.S. Pat. No. 6,155,972 have beendemonstrated to be capable of providing effective treatment forcongestive heart failure in certain patients. Surgical procedures forplacing the jacket on a diseased heart include a full sternotomy inwhich the sternum or breast bone of the patient is cut and separated toprovide an open-field access to the heart. During such an openprocedure, a surgeon has direct visualization and a wide field of accessto the heart. The base end of the jacket is opened and placed over theapex of the heart with the base end advanced to the atrial-ventriculargroove (A-V groove). The surgeon can then secure the base end in thedesired position through sutures or the like. It is noted in theAlferness U.S. Pat. No. 5,702,343 that other suitable securingarrangements include a circumferential attachment device such as a cord,suture, band, adhesive or shape memory element which passes around thecircumference of the base of the jacket. The ends of the attachmentdevice can be fastened together to secure the jacket in place.

Also, the surgeon can adjust the jacket on the heart by gathering anyexcess material and suturing the excess material together to get adesired amount of tension of the jacket on the heart. The Alferness U.S.Pat. No. 5,702,343 also describes an alternative approach in which thejacket includes a mechanism for selectively adjusting the volumetricsize of the jacket. A slot that opens on the base of the jacket andextends toward the apex end is described as one mechanism for providingthe size adjusting function. Adjustment mechanisms are also disclosed inthe Shapland et al. U.S. Pat. No. 6,425,856 and the Kung et al. U.S.Pat. No. 6,508,756. Other cardiac support devices are disclosed in Lauet al. U.S. Pat. Nos. 6,595,912 and 6,612,978.

While the open-chest implantation procedure is acceptable, it isdesirable to be able to place a jacket on the heart through laparoscopicor other less-invasive procedures. During less-invasive procedures, thesurgeon may have more limited access to the heart and more limitedability to ensure placement and alignment of a jacket on the heart.Properly placing and securing the jacket on the heart duringminimally-invasive delivery procedures of these types can be moredifficult than in open-chest procedures.

There is, therefore, a continuing need for improved structures forsecuring jackets or other cardiac support devices to the heart. Inparticular, there is a need for improved structures for attaching andfitting the devices to the heart. Structures of these types that areself-adjusting would be especially desirable. The structures should becapable of providing the attaching and/or fitting functions withoutinterfering with the therapeutic functions of cardiac support devices.Structures that meet these objectives and can be used in connection withminimally-invasive delivery procedures would also be desirable.

SUMMARY OF THE INVENTION

The present invention is an improved cardiac support device. The deviceincludes a jacket having a base region for constraining cardiacexpansion. Attachment structure on a base region of the jacketself-secures the jacket to a heart. The attachment structure is anelastic structure. Examples of the attachment structure includeundulating metal and polymer elements, a silicone band and elastomericthreads.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to one embodiment of thepresent invention with the attachment mechanism in a stressed state on aheart shown in phantom lines.

FIG. 2 is an illustration of the cardiac support device of FIG. 1 withthe attachment mechanism in a relaxed state.

FIG. 3 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention with the attachment mechanism in a stressed state.

FIG. 4 is an illustration of the cardiac support device of FIG. 3 withthe attachment mechanism in a relaxed state.

FIG. 5 is an isometric view of a cardiac support device including ajacket and a fitting mechanism according to another embodiment of thepresent invention with the fitting mechanism in a stressed state.

FIG. 6 is an illustration of the cardiac support device of FIG. 4 withthe fitting mechanism in a relaxed state.

FIG. 7 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention with the attachment mechanism in a stressed state.

FIG. 8 is an illustration of the cardiac support device of FIG. 7 withthe attachment mechanism in a relaxed state.

FIG. 9 is an isometric view of a cardiac support device including ajacket and a fitting mechanism according to another embodiment of thepresent invention.

FIG. 10 is an illustration of a cardiac support device including ajacket and a securing mechanism according to another embodiment of thepresent invention, with the securing mechanism in a relaxed state.

FIG. 11 is an illustration of the cardiac support device of FIG. 10 withthe securing mechanism in a drawn state.

FIG. 12 is an illustration of a cardiac support device including ajacket and a fitting mechanism according to another embodiment of thepresent invention.

FIG. 13 is a detailed cross-sectional view of a portion of a cardiacsupport device shown in FIG. 12 on the epicardial surface of a heart.

FIG. 14 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention, with portions of the jacket removed to show theattachment mechanism.

FIG. 15 is a detailed view of the attachment mechanism shown in FIG. 14.

FIG. 16 is a view of a single turn of the attachment mechanism of FIG.15.

FIG. 17 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention.

FIG. 18 is a detailed view of the attachment mechanism shown in FIG. 17.

FIG. 19 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention, with portions of the jacket removed to show theattachment mechanism.

FIG. 20 is a detailed view of the attachment mechanism shown in FIG. 19.

FIG. 21 is an isometric view of a cardiac support device including ajacket and an attachment mechanism according to another embodiment ofthe present invention.

FIG. 22 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 23 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 24 is a detailed illustration of the attachment mechanism shown inFIG. 23.

FIG. 25 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 26 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 27 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 28 is an illustration of another embodiment of a cardiac supportdevice having a fitting mechanism in accordance with the invention.

FIG. 29 is an illustration of another embodiment of a cardiac supportdevice having a fitting mechanism in accordance with the invention.

FIG. 30 is an illustration of another embodiment of a cardiac supportdevice having an attachment mechanism in accordance with the invention.

FIG. 31 is an illustration of another embodiment of a cardiac supportdevice having a fitting mechanism in accordance with the invention.

FIG. 32 is an illustration of another embodiment of a cardiac supportdevice having a securing mechanism in accordance with the invention.

FIG. 33 is an illustration of another embodiment of a cardiac supportdevice having a securing mechanism in accordance with the invention.

FIG. 34 is an illustration of another embodiment of a cardiac supportdevice having a securing mechanism in accordance with the invention.

FIGS. 35A-35D are force-extension graphs illustrating characteristics ofone embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1 and 2 illustrate a cardiac support device 10 that includes acardiac jacket 12 and a securing structure or mechanism in the form of aself-attachment structure or mechanism 14 in accordance with a firstembodiment of the invention. The jacket 12 can be similar or identicalto those described in any of the following U.S. patents assigned toAcorn Cardiovascular, Inc., all of which are incorporated herein byreference: U.S. Pat. No. 5,702,343; U.S. Pat. No. 6,155,972; U.S. Pat.No. 6,193,648; U.S. Pat. No. 6,482,146; U.S. Pat. No. 6,682,476; U.S.Pat. No. 6,902,524; U.S. Pat. No. 6,425,856; U.S. Pat. No. 6,908,426;U.S. Pat. No. 6,572,533; U.S. Pat. No. 6,673,009; and U.S. Pat. No.6,951,534. In still other embodiments the jacket 12 can be similar oridentical to those described in U.S. Pat. No. 6,702,732 and U.S. Pat.No. 6,723,041, both of which are assigned to Paracor and areincorporated herein by reference. These examples of jacket 12 are notlimiting, and the securing mechanisms described herein can beincorporated into other cardiac jacket structures.

In one preferred embodiment, the jacket 12 has a structure, complianceand elasticity, of that described in the Alferness et al. U.S. Pat. No.6,482,146. As shown in FIGS. 1 and 2, this embodiment of jacket 12 is agenerally conical device having a base region or end 16 and an apex end18. The base end 16 is open to permit access to the internal volume ofthe jacket 12. The jacket 12 can also has a base end 16 with areinforced hem as disclosed in U.S. Pat. No. 6,155,972. The jacketmaterial is an open-cell construction of a polyester knit material asmore fully described in U.S. Pat. No. 6,482,146. In the various Figures,the apex end is shown closed. It will be appreciated the apex end 18 maybe an open or closed apex (an open apex embodiment of the invention isshown in FIG. 26).

The conical jacket 12 is sized to cover the lower portion LP of a heartH (shown only in FIG. 1 in phantom lines) which would include the leftand right ventricles of the heart. The jacket is typically configured sothe base end 16 is sized and located to engage and surround theatrial-ventricular groove (A-V groove). In other embodiments of theinvention (not shown) the jacket 12 is configured so the base end 16 islocated to engage and surround portions of the heart above and/or belowthe A-V groove. By way of example, in other embodiments (not shown) thejacket 12 is configured to cover an upper portion UP of the heart H(which includes the left and right atria).

The attachment mechanism 14 is a circumferential and elastic structuretypically located on or near a base portion such as the base end 16 ofthe jacket 12. In the embodiment shown in FIGS. 1 and 2, the attachmentmechanism 14 is a one-piece structure that extends completely around thejacket 12. Other embodiments described below are multi-piece structures,with each piece circumferentially extending around only portions of thejacket 12. Still other embodiments (not shown) have a one undulatingelement that extends only partially around the circumference of thejacket 12 (e.g., about one-quarter, one-third or one-half of the jacketcircumference). The elastic characteristics of the attachment mechanism14 enable the mechanism to be expanded by an applied force from a first(e.g., neutral) state at which the mechanism has a first circumferentiallength or circumference (and diameter) to a second (e.g., stressed)state at which the mechanism has a larger circumferential length orcircumference (and diameter), and to return toward the first state uponthe removal of the applied force. In one embodiment of the invention theelasticity of the attachment mechanism 14 is greater than the elasticityof the jacket 12. In other embodiments the attachment mechanism 14 hasan elasticity that is equal to or less than the elasticity of the jacket12. The compliance of the attachment mechanism 14 can be greater than,equal to or less than the compliance of the jacket 12.

The attachment mechanism 14 shown in FIGS. 1 and 2 is an undulatingresilient element. The resilient element can, for example, be stainlesssteel or other metal element, or wire of these materials. Alternatively,or in addition, the undulating resilient element can include a polymermaterial such as elastomeric silicone. In still other embodiments theundulating resilient element is a shape memory material such as nitinol,or a wire of these materials. Other shape memory materials (e.g.,polymers) can also be used for the undulating resilient elements.

In still other embodiments the undulating resilient element can beformed from or coated with a bio-resorbable material. The importance ofand need for the attachment function provided by the attachmentmechanism 14 can decline with time following the implantation of cardiacsupport device 10. For example, as a result of fibrosis, epicardial,pericardial and other tissues of the heart H adjacent to the jacket 12will grow into and surround the material of the jacket, therebyeffectively causing the jacket to be attached to the heart.

The attachment mechanism 14 can be attached directly at one or morelocations to the jacket 12 by, for example, sutures, adhesive, clips orother structures. Alternatively, the attachment mechanism 14 can beretained on the jacket 12 in a free-floating form within a pocket orchannel around the base end 16 of the jacket 12. For example, such achannel can be formed by a hem on the base end 16 of the jacket.

When the base end 16 of the cardiac support device 10 is stretched toincrease the size of the opening from a neutral state, the attachmentmechanism 14 is biased to a stressed state. In the stressed state shownin FIG. 1, the spacing S₁ of the undulations of the resilient elementare enlarged beyond the spacing S₂ when in the neutral state shown inFIG. 2. With the cardiac support device 10 in the stressed state and thebase end 16 opened to a size that is larger than the size of the heart Hto which the device is being applied, the base end is slipped over theapex of the heart into position surrounding the valvular annulus. Theforce holding the attachment mechanism 14 is then released, allowing theattachment mechanism to return toward its neutral state and engage theheart H at the A-V groove. The attachment mechanism 14 therebyself-secures the jacket 12 to the heart H.

After the cardiac support device 10 is implanted on the heart H, thejacket 12 provides the therapeutic functions described in the patentsidentified above. The attachment mechanism 14 holds the base end 16 ofthe device 10 on the heart (e.g., at the A-V groove) and reduceslikelihood of slippage of the device 10 following placement at thedesired position on the heart. The added support of the attachmentmechanism 14 at the base end 16 can be particularly advantageous in aless-invasive delivery procedure where the surgeon does not haverelatively wide freedom of access to the heart.

Attachment mechanism 14 will typically be in a stressed stateimmediately following the implantation of cardiac support device 10 on adiseased heart H. Studies have shown that after a period of timefollowing implantation, jackets 12 can cause the heart H to remodel orreduce in size. In preferred embodiments of the cardiac support device10, the attachment mechanism 14 has a neutral state circumference thatis generally equal to, but not less than, the native circumference of anequivalent-sized healthy heart. In this embodiment of the invention theforces applied to the heart H by the attachment mechanism 14 if and whenthe heart H is remodeled to its equivalent original size will besufficiently low that they will not overcome the outwardly directedforces of the heart itself. In other embodiments of the invention, theattachment mechanism 14 is sized or otherwise configured so that it isin a stressed state, and overdrives the heart H to modify the heart andprovide coaptation of the valve annulus geometry. The attachmentmechanism 14 can add tension to the heart H at the base end 16 of thejacket 12. This tension can urge opposing tissue on the heart H to bulgeinto open spaces of the jacket 12. By way of example, FIG. 13illustrates how the attachment mechanism 14 and portions 20 of jacket 12urge against the tissue T to create bulging B in the open spaces definedbetween the attachment mechanism 14 and jacket portions 20. The bulges Bresist movement of the jacket 12 relative to the tissue T. In stillother embodiments (not shown), anchors, snares, texturedfriction-enhancing elements or other structures can be incorporated intothe cardiac support device 10 (including attachment mechanism 14) toenhance the attachment function.

FIGS. 3 and 4 illustrate a cardiac support device 110 having a jacket112 and a self-attachment structure or mechanism 114 in accordance withanother embodiment of the invention. Jacket 112 can be substantiallyidentical or similar to jacket 12 described above. Attachment mechanism114 has a plurality (four are shown in the illustrated embodiment) ofseparate attachment mechanism segments 114 a-114 d. As shown, attachmentmechanism segments 114 a-114 d are arranged in a circumferential patternaround the base end 116 of jacket 112. In FIG. 3, the segments 114 a-114d of the attachment mechanism 114 are shown in a stressed state,stretched against their elastic bias. FIG. 4 shows the attachmentmechanism 114 in a lower stress state than in FIG. 3 (e.g., in a statethat the attachment mechanism can have after implantation of the cardiacsupport device 110 on a heart H). Other than the differences describedabove and illustrated in FIGS. 3 and 4, the characteristics (e.g.,compliance and elasticity), function and operation of attachmentmechanism 114 can be substantially identical or similar to attachmentmechanism 14 described above. Similarly, the attachment mechanism 114can be attached the jacket 112 in a manner substantially identical orsimilar to the above-described method by which attachment mechanism 14is attached to jacket 12.

FIGS. 5 and 6 illustrate a cardiac support device 210 having a jacket212 and a securing mechanism in the form of a self-fitting mechanism 214in accordance with another embodiment of the invention. Jacket 212 canbe substantially identical or similar to jacket 12 described above.Fitting mechanism 214 is an elastic structure located on the jacket 212between the base end 216 and apex end 218. In the embodiment shown inFIGS. 5 and 6, the fitting mechanism 214 has a plurality (three areshown) of separate fitting mechanism segments 214 a-214 c that arespaced from one another along a generally longitudinal axis between thebase end 216 and the apex end 218. Each of the fitting mechanismsegments 214 a-214 c extends circumferentially in a generally transversedirection around a portion of the jacket 212. The elastic shape memorycharacteristics of the fitting mechanism 214 enable the mechanism to beexpanded by an applied force from a first (e.g., neutral) state at whichthe mechanism has a first length to a second state at which themechanism has a larger length, and to return toward the first state uponthe removal of the applied force. In one embodiment of the invention theelasticity of the fitting mechanism 214 is greater than the elasticityof the jacket 212. In other embodiments the fitting mechanism 214 has anelasticity that is equal to or less than the elasticity of the jacket212. The compliance of the fitting mechanism 214 can be greater than,equal to or less than the compliance of the jacket 212. In theembodiment shown in FIGS. 5 and 6 the fitting mechanism segments 214a-214 c can be similar or identical in general structure to theattachment mechanism segments 114 a-114 d described above in connectionwith cardiac support device 110. However, the fitting mechanism segments214 a-214 c can have differences over the attachment mechanism segments114 a-114 d (e.g., different lengths, materials, elasticity and springforces) to provide the desired fitting functionality of the fittingmechanism 214 as described below. The fitting mechanism segments 214a-214 c can also be attached to the jacket 214 in ways that aresubstantially identical or similar to the above-described approaches bywhich the adjustment mechanism segments 114 a-114 d are attached tojacket 112. In still other embodiments (not shown) the fitting mechanism214 can extend greater or lesser distances around, or completely around,the jacket 212.

When the cardiac support device 210 is stretched (in a generallytransverse or circumferential direction) between its base end 216 andapex end 218 from its neutral state, the fitting mechanism 214 is biasedto a stressed state shown in FIG. 5. The cardiac support device 210 canthen be positioned on the heart H in the manner described above inconnection with device 10. The force holding the fitting mechanism 214is then released, allowing the fitting mechanism to return toward itsneutral state as shown in FIG. 6.

After the cardiac support device 210 is implanted on the heart H, thefitting mechanism 214 will be in a stressed state applying a force thatcauses the jacket 212 be properly sized (i.e., to snugly fit) on theheart between the base end 216 and apex end 218. The fitting functionprovided by the fitting mechanism 214 enables the jacket 212 to providethe therapeutic functions described in the patents identified above.Although not shown in FIGS. 5 and 6, other embodiments of cardiacsupport device 210 also include attachment mechanisms such as thosedescribed herein.

FIGS. 7 and 8 illustrate a cardiac support device 410 having a jacket412 and a self-attachment mechanism 414 in accordance with anotherembodiment of the invention. Jacket 412 can be substantially identicalor similar to jacket 12 described above. Attachment mechanism 414 has aplurality (four are shown in the illustrated embodiment) of attachmentmechanism rings 414 a-414 d. Attachment mechanism rings 414 a-414 d canbe made from the same materials, and secured to the jacket 412 by thesame approaches, as those of attachment mechanism 14 described above.The characteristics, function and operation of attachment mechanism 414can be substantially identical or similar to those of attachmentmechanism 14 described above. Briefly, when the base end 416 of thecardiac support device 410 is stretched for implantation on a heart H,the attachment mechanism rings 414 a-414 d will be deformed and biasedto a stressed state (e.g., as shown in FIG. 7). After being implanted ona heart H, the force holding the attachment mechanism 414 is released,allowing the attachment mechanism to return toward the neutral state asshown in FIG. 8 and perform the attachment function described above.

FIG. 9 illustrates a cardiac support device 510 having a jacket 512 anda self-fitting mechanism 514 in accordance with another embodiment ofthe invention. Jacket 512 can be substantially identical or similar tojacket 12 described above. Cardiac support device 510 can be implantedon a heart H in a manner substantially identical or similar to that ofdevice 210 described above. The fitting mechanism 514 is an elasticpanel of material having characteristics and functions that aresubstantially identical or similar to those of the fitting mechanism 214of cardiac support device 210. Fitting mechanism 514 can, for example,be a panel of material generally of the type described in theabove-identified Alferness et al. U.S. Pat. No. 6,482,146 and Girard etal. U.S. Pat. No. 6,951,534, configured to provide the desired fittingfunctionality of the fitting mechanism. In one embodiment, the panel ofmaterial forming fitting mechanism 514 is similar to the materialforming the jacket 512, with the material of the jacket being heat setand the material of the fitting mechanism not being heat set. Heatsetting processes such as those described in U.S. Pat. No. 6,951,534provides a number of attributes to the material including an increasedcompliance over the material that is not heat set. The panel of materialforming the fitting mechanism 514 can be sewn or otherwise attached tothe adjacent portions of the jacket 512. In other embodiments (notshown) the panel of material forming the fitting mechanism 514 canoverlay the material forming the jacket 512 (i.e., the panel can be anadditional member on the jacket, rather than a member in place of aportion of the jacket). The shape and size of the panel of material canbe selected, along with the elasticity and other characteristics of thematerial, to provide the desired fitting functionality. By way ofexample, in embodiments where the panel of material is a woven textilematerial such as those described in the above-identified Alferness etal. U.S. Pat. No. 6,482,146 and Girard et al. U.S. Pat. No. 6,951,534,the different weaves or knits, and/or different thread materials, can beused to provide the desired characteristics of the material.Non-limiting examples of the shapes the panel of material includediamond, oval, ellipsoid and trapezoid. Furthermore, although not shownin FIG. 9, cardiac support device 510 can also include an attachmentmechanism such as any of those described herein. The panel of fittingmechanism 514 can also extend for greater or lesser distances around thecircumference of jacket 512.

FIGS. 10 and 11 illustrate a cardiac support device 610 having a jacket612 with draw strings 630 and 632. Jacket 612 can be substantiallyidentical or similar to jacket 12 of cardiac support device 10 describedabove. As shown, the draw strings 630 and 632 are incorporated into themesh or open cell structure of the material forming the jacket 612 froma location near the base end 616 to a location near the apex end 618. Asshown in FIG. 11, pulling the draw strings 630 and 632 causes thematerial of jacket 612 to narrow or shorten in length in thecircumferential or transverse direction. Draw strings 630 and 632 cantherefore be used to attach and/or fit the jacket 612 to the heart H.

FIG. 12 illustrates a cardiac support device 710 having a jacket 712 anda self-fitting mechanism 714 in accordance with another embodiment ofthe invention. Jacket 712 can be substantially identical or similar tojacket 12 of cardiac support device 10 described above. Fittingmechanism 714 is an elastic structure located on the jacket 712 betweenthe base end 716 and apex end 718. In the embodiment shown in FIG. 12,the fitting mechanism 714 has a plurality (three are shown) of separatefitting mechanism segments 714 a-714 c that are spaced from one anotherbetween the base end 216 and apex end 218. Each of the fitting mechanismsegments 714 a-714 c extends circumferentially in a generally transversedirection around a portion of the jacket 712. Fitting mechanism segments714 a-714 c are helical coils in the embodiment shown in FIG. 12. Thesehelical coil fitting mechanism segments 714 a-714 c can be made from thesame materials, and secured to the jacket 712 by the same approaches, asthose of the fitting mechanism segments 214 a-214 c of cardiac supportdevice 210 described above. The characteristics, functions and operationof fitting mechanism 714 can be substantially identical or similar tothose of fitting mechanism 214 described above. The fitting mechanismsegments 714 a-714 c can also extend for greater or lesser distancesaround the circumference of jacket 712.

FIG. 14 illustrates a cardiac support device 810 having a jacket 812 anda self-attachment mechanism 814 in accordance with another embodiment ofthe invention. Jacket 812 can be substantially identical or similar tojacket 12 of cardiac support device 10 described above. The attachmentmechanism 814 is a helical coil that extends around the base end 816 ofthe jacket 812. As perhaps best shown in FIGS. 15 and 16, the helicalcoil of attachment mechanism 814 can be flattened to provide enhancedsurface area for engagement with the heart H. The helical coil ofattachment mechanism 814 can be made from the same materials, andsecured to the jacket 812 by the same approaches, as those of attachmentmechanism 14 of cardiac support device 10 described above. Thecharacteristics, functions and operation of attachment mechanism 814 canbe substantially identical or similar to those of attachment mechanism14 of cardiac support device 10 described above. In the embodiment shownin FIG. 14, the helical coil of attachment mechanism 814 is a singlemember that extends most or all of the way around the base end 816 ofjacket 812. In other embodiments (not shown), the attachment mechanism814 can have a plurality of separate helical coil segments arranged in acircumferential pattern around the base end 816 of the jacket 812 (e.g.,similar to the arrangement of separate attachment mechanism segments 114a-114 d of cardiac support device 110 described above), or can be asingle member having two ends that extends only around a portion of thejacket 812.

FIG. 17 illustrates a cardiac support device 910 having a jacket 912 anda self-attachment mechanism 914 in accordance with another embodiment ofthe invention. Jacket 912 can be substantially identical or similar tojacket 12 of cardiac support device 10 described above. The attachmentmechanism 914, which is shown in greater detail in FIG. 18, includes aplurality of rings 915 interconnected by links 917. In the illustratedembodiment, and when in the neutral state as shown in FIGS. 17 and 18,the rings 915 are circular and the links are linear. Attachmentmechanism 914 can be made from the same materials, and secured to thejacket 912 by the same approaches, as those of the attachment mechanism14 of cardiac support device 10 described above. The characteristics,functions and operation of attachment mechanism 914 can be substantiallyidentical or similar to those of attachment mechanism 14 of cardiacsupport device 10 described above. Briefly, when the base end 916 of thecardiac support device 910 is stretched for implantation on a heart H,the attachment mechanism rings 915 will be deformed and biased to astressed state (not shown). After being implanted on a heart H, theforce holding the attachment mechanism 914 is released, allowing theattachment mechanism to return toward the neutral state and perform theattachment function.

FIG. 19 illustrates a cardiac support device 1010 having a jacket 1012and a self-attachment mechanism 1014 in accordance with anotherembodiment of the invention. Jacket 1012 can be substantially identicalor similar to jacket 12 of cardiac support device 10 described above.The attachment mechanism 1014, which is shown in greater detail in FIG.20, includes a hoop having two free ends 1019 and 1021. In theembodiment shown in FIGS. 19 and 20 the hoop is a solid member having across section in the shape of a generally thin and elongated polygon anda major surface that will be located adjacent to the heart H. In otherembodiments (not shown, the hoop can take other forms (e.g., haveapertures or a circular or other non-trapezoidal cross section). Theends 1019 and 1021 overlap in the illustrated embodiment. In otherembodiments (not shown), the ends 1019 and 1021 do not overlap.Attachment mechanism 1014 can be made from the same materials, andsecured to the jacket 1012 by the same approaches, as attachmentmechanism 14 of cardiac support device 10 described above. Thecharacteristics, functions and operation of attachment mechanism 1014can be similar to those of attachment mechanism 14 of cardiac supportdevice 10 described above. Briefly, when the base end 1016 of thecardiac support device is stretched for implantation on a heart H, theends 1019 and 1021 move with respect to one another as the hoop isdeformed and biased to a stressed state (not shown). After beingimplanted on a heart H, the force holding the attachment mechanism 1014is released, allowing the attachment mechanism to return toward theneutral state and perform the attachment function.

FIG. 21 illustrates a cardiac support device 1110 having a jacket 1112and a self-attachment mechanism 1114 in accordance with anotherembodiment of the invention. Jacket 1112 can be substantially identicalor similar to jacket 12 of cardiac support device 10 described above.The attachment mechanism 1114 includes a plurality of filamentary orthread-like elastomeric bands 1114 a-1114 c. In other embodiments (notshown) the attachment mechanism 1114 has more or fewer bands 1114 a-1114c. Attachment mechanism 1114 can be formed from elastomeric materialsincluding polymers or silicone. Alternatively, the attachment mechanism1114 can be formed from other materials in a manner that provides theelasticity and compliance characteristics. Attachment mechanism 1114 canbe secured to the jacket 1112 by the same approaches as attachmentmechanism 14 of cardiac support device 10 described above. Thecharacteristics, functions and operation of attachment mechanism 1114can be similar to those of attachment mechanism 14 of cardiac supportdevice 10 described above.

FIG. 22 illustrates a cardiac support device 1110′ having a jacket 1112′and a self-attachment mechanism 1114′ in accordance with anotherembodiment of the invention. Attachment mechanism 1114′ includes pads1123 attached to bands 1114 a′ and 1114 c′. Other than the addition ofpads 1123, cardiac support device 1110′, including attachment mechanism1114′, can be substantially identical or similar to cardiac supportdevice 1110 described above. Pads 1123 can be formed from polymersand/or other materials such as metals, and can be attached to bands 1114a′-1114 c′ or jacket 1112 by sutures, adhesive, clips or otherstructures or approaches. Alternatively, the pads 1123 can includeapertures or other structures (not shown) through which the bands 1114a′-1114 c′ extend. In the illustrated embodiment the pads 1123 are onthe inside surface of the jacket 1112′ so they will directly engage theheart H. when the cardiac support device 1110′ is implanted. In otherembodiments (not shown) the pads 1123 can be located so the material ofthe jacket 1112′ will be between the pads and the heart H when thedevice 1110′ is implanted.

Pads 1123 can facilitate the attachment of the jacket 1112′ to the heartH, and can (but need not have) a structured or textured surface toenhance this functionality by increasing the friction between the padsand the heart. Examples of the types of surface structures that can beincluded on pads 1123 include protuberances, grit and othertissue-engaging structures such as those disclosed in the Meyer U.S.Patent Application Publication No. US 2006/0009675, which isincorporated herein by reference in its entirety.

FIG. 23 illustrates a cardiac support device 1210 having a jacket 1212and a self-attachment mechanism 1214 in accordance with anotherembodiment of the invention. Jacket 1212 can be substantially identicalor similar to jacket 12 of cardiac support device 10 described above.The attachment mechanism 1214, which is shown in greater detail in FIG.24, is a band formed from elastomeric polymer or other material such assilicone, and includes a plurality of apertures 1225. The band has across section generally in the shape of an elongated polygon, and has amajor surface that will be located adjacent to the heart H. In theillustrated embodiment, the apertures 1225 are circular when theattachment mechanism 1214 is in its neutral state. The apertures 1225have other shapes (e.g., oval or trapezoidal) in other embodiments (notshown). Attachment mechanism 1214 can be secured to the jacket 1212 bythe same approaches as attachment mechanism 14 of cardiac support device10 described above. The characteristics, functions and operation ofattachment mechanism 1214 can be substantially identical or similar tothose of attachment mechanism 14 of cardiac support device 10 describedabove. Briefly, when the base end 1216 of the cardiac support device1210 is stretched for implantation on a heart H, the attachmentmechanism 1214, including the apertures 1225, will be deformed andbiased to a stressed state (not shown). After being implanted on a heartH, the force holding the attachment mechanism 1214 is released, allowingthe attachment mechanism to return toward the neutral state and performthe attachment function.

FIG. 25 illustrates a cardiac support device 1310 having a jacket 1312and a self-attachment mechanism 1314 in accordance with anotherembodiment of the invention. Jacket 1312 can be substantially identicalor similar to jacket 12 of cardiac support device 10 described above.The attachment mechanism 1314 is an elastic band of open cell andpreferably knit material. The material can, for example, be generally ofthe type described in the above-identified Alferness et al. U.S. Pat.No. 6,482,146 and Girard et al. U.S. Pat. No. 6,951,534, configured toprovide the desired attachment functionality of the attachment mechanism1314. Like the panel of material forming fitting mechanism 514 ofcardiac support device 510 described above, characteristics of thematerial of attachment mechanism 1314 can be controlled by heat settingor not heat setting the material. Attachment mechanism 1314 can besecured to the jacket 1312 by the same approaches as attachmentmechanism 14 of cardiac support device 10 described above.Alternatively, the attachment mechanism 1314 can be attached (e.g.,sewn) to the upper edge of the base end 1316 of jacket 1312, or it canbe attached in an overlapping relationship with the jacket. In otherembodiments the attachment mechanism 1314 can be integrally formed(e.g., interwoven) with the material of jacket 1312. Thecharacteristics, functions and operation of attachment mechanism 1314can be substantially identical or similar to those of attachmentmechanism 14 of cardiac support device 10 described above.

FIG. 26 illustrates a cardiac support device 1310′ having a jacket 1312′and a self-attachment mechanism 1314′ in accordance with anotherembodiment of the invention. Jacket 1312′ has an open apex end 1318′.With the exception of the open apex end 1318′, jacket 1312′ can besubstantially identical or similar to jacket 1312 of cardiac supportdevice 1310 described above. Jackets having open apex ends such as 1318′can be incorporated into any and all embodiments of the inventiondescribed herein. Also, attachment mechanism 1314′ can be substantiallyidentical or similar to attachment mechanism 1314 of cardiac supportdevice 1310 described above.

FIG. 27 illustrates a cardiac support device 1210′ having a jacket 1212′and a self-attachment mechanism 1214′ in accordance with anotherembodiment of the invention. Jacket 1212′ can be substantially identicalor similar to jacket 1212 of cardiac support device 1210 describedabove. The attachment mechanism 1214′ is a band of elastomeric polymeror other materials such as silicone, and is solid (i.e., does notcontain apertures). Attachment mechanism 1214′ has a cross section inthe shape of a generally thin and elongated polygon and a major surfacethat will be located adjacent to the heart H. With the exception of itssolid nature, attachment mechanism 1214′ can be substantially identicalor similar to attachment mechanism 1214 of cardiac support device 1210described above. Attachment mechanism 1214′ can be secured to jacket1212′ by the same approaches as attachment mechanism 1214 of cardiacsupport device 1210 described above.

FIG. 28 illustrates a cardiac support device 1410 having a jacket 1412and a self-fitting mechanism 1414 in accordance with another embodimentof the invention. Jacket 1412 can be substantially identical or similarto jacket 12 of cardiac support device 10 described above. The fittingmechanism 1414 is an elastomeric panel of material havingcharacteristics and functions that are substantially identical orsimilar to those of the fitting mechanism 514 of cardiac support device510 described above. In the illustrated embodiment, fitting mechanism1414 is a solid panel of elastomeric polymer or other material such assilicone. The panel of material forming the fitting mechanism 1414 canbe sewn or otherwise attached to the adjacent portions of the jacket1412. In other embodiments (not shown) the panel of material forming thefitting mechanism can overlay the material forming the jacket (i.e., thepanel can be an additional member on the jacket, rather than a member inplace of a portion of the jacket). The shape and size of the panel ofmaterial can be selected, along with the elasticity and compliancecharacteristics of the material, to provide the desired fittingfunctionality. Furthermore, although not shown in FIG. 28, cardiacsupport device 1410 can also include an attachment mechanism such as anyof those described herein.

FIG. 29 illustrates a cardiac support device 1410′ having a jacket 1412′and a self-fitting mechanism 1414′ in accordance with another embodimentof the invention. Fitting mechanism 1414′ includes a plurality ofapertures 1427. With the exception of the apertures 1427, fittingmechanism 1414′ can be substantially identical or similar to fittingmechanism 1414 of cardiac support device 1410 described above. Althoughshown as transversely oriented elongated members in the illustratedembodiment, the apertures 1427 can have other shapes, sizes and/ororientations. Jacket 1412′ can be substantially identical or similar tojacket 1412 of the cardiac support device 1410 described above.

FIG. 30 illustrates a cardiac support device 1510 having a jacket 1512and a self-attachment mechanism 1514 in accordance with anotherembodiment of the invention. Jacket 1512 can be substantially identicalor similar to jacket 12 of cardiac support device 10 described above.Attachment mechanism 1514 includes one or more elastomeric filaments orthreads 1529 or other elongated members interwoven into the material ofthe jacket 1512 at the base end 1516. The characteristics (e.g.,compliance and elasticity), function and operation of attachmentmechanism 1514 can be substantially identical or similar to those ofattachment mechanism 14 of cardiac support device 10 described above. Inthe illustrated embodiment the material of jacket 1512 has an open cellform. A knit fabric of the types described above can be used formaterial of this type. In other embodiments (not shown) jacket 1512 isconstructed of non-woven materials. In still other embodiments (notshown) the jacket 1512 is constructed of knit fabric, and theelastomeric threads 1529 or other elements are incorporated into threadsof other materials from which the fabric is knit (i.e., in bundledthreads).

FIG. 31 illustrates a cardiac support device 1610 having a jacket 1612and a self-fitting mechanism 1614 in accordance with another embodimentof the invention. Jacket 1612 can be substantially identical or similarto jacket 512 of cardiac support device 510 described above. Fittingmechanism 1614 includes one or more elastomeric threads 1629 or otherelongated members interwoven into the material of the jacket 1612between the base end 1616 and apex end 1618 of the jacket. Thecharacteristics (e.g., compliance and elasticity), function andoperation of fitting mechanism 1614 can be substantially identical orsimilar to those of fitting mechanism 514 of cardiac support device 510described above. In the illustrated embodiment the material of jacket1612 is a knit fabric. In other embodiments (not shown) jacket 1612 isconstructed of non-woven materials. In still other embodiments (notshown) the jacket 1612 is constructed of knit fabric, and theelastomeric threads 1629 or other elements are incorporated into threadsof other materials from which the fabric is woven (i.e., in bundledthreads).

FIG. 32 illustrates a cardiac support device 1710 having a jacket 1712and a securing mechanism 1714 in accordance with another embodiment ofthe invention. Jacket 1712 can be substantially identical or similar tojacket 12 of cardiac support device 10 described above. Securingmechanism 1714 includes one or more elastomeric threads 1729 or otherelongated members interwoven into the material of the jacket 1712 alongthe base end 1716 and between the base end 1716 and apex end 1718 of thejacket. The securing mechanism 1714 effectively provides the function ofboth the attachment mechanisms and fitting mechanisms of the otherembodiments of the invention described herein. The characteristics(e.g., compliance and elasticity), function and operation of securingmechanism 1714 can be substantially identical or similar to those of theother attachment and fitting mechanisms described herein. In theillustrated embodiment the material of jacket 1712 is a knit fabric. Inother embodiments (not shown) jacket 1712 is constructed of non-wovenmaterials. In still other embodiments (not shown) the jacket 1712 isconstructed of knit fabric, and the elastomeric threads 1729 or otherelements are incorporated into threads of other materials from which thefabric is woven (i.e., in bundled threads).

FIG. 33 illustrates a cardiac support device 1210″ having a jacket 1212″and a self-attachment mechanism 1214″ in accordance with anotherembodiment of the invention. Jacket 1212″ can be substantially identicalor similar to jacket 1212′ of cardiac support device 1210′ describedabove. The attachment mechanism 1214″ is a solid band of elastomericpolymer or other materials such as silicone that has a pair of ends(i.e., is not continuous) and does not extend completely around thejacket 1212″. With the exception of the fact that it is not continuous,attachment mechanism 1214″ can be substantially identical or similar toattachment mechanism 1214′ of cardiac support device 1210′ describedabove. Attachment mechanism 1214″ can be secured to jacket 1212″ by thesame approaches as attachment mechanism 1214′ of cardiac support device1210′ described above. In another embodiment (not shown) the solid bandof attachment mechanism 1214″ extends a lesser distance around thecircumference of jacket 1214″. Still other embodiments (not shown)include a plurality of segments of bands such as that shown in FIG. 33that are spaced around all or portions of the circumference of jacket1214″.

FIG. 34 illustrates a cardiac support device 1210′ having a jacket1212′″ and a self-attachment mechanism 1214′″ in accordance with anotherembodiment of the invention. Jacket 1212′″ can be substantiallyidentical or similar to jacket 1212′ of cardiac support device 1210′described above. The attachment mechanism 1214′ includes a plurality(three are shown in the illustrated embodiment) of solid bands 1214a′″-1214 c′″ of elastomeric polymer or other materials such as silicone.With the exception of the fact that it includes a plurality of bands1214 a′″-1214 c′″, attachment mechanism 1214′″ can be substantiallyidentical or similar to attachment mechanism 1214′ of cardiac supportdevice 1210′ described above. The bands 1214 a′″-1214 c′ can have across section in the shape of a polygon, a circle or other shapes. Ingeneral, bands 1214 a′″-1214 c′ are larger in cross sectional dimensionthan the filamentary or thread-like elastomeric bands 1114 a-1114 c ofattachment mechanism 1114 of cardiac support device 1110 describedabove. Attachment mechanism 1214′″ can be secured to jacket 1212′″ bythe same approaches as attachment mechanism 1214′ of cardiac supportdevice 1210′ described above. In another embodiment (not shown)attachment mechanism 1214′″ extends a lesser distance around thecircumference of jacket 1214′″. Still other embodiments (not shown)include a plurality of segments of bands such as that shown in FIG. 34that are spaced around all or portions of the circumference of jacket1214′″.

An example of the operation of one embodiment of the attachmentmechanism 14 and jacket 12 of a cardiac support device 10 can bedescribed with reference to FIGS. 35A-35D. FIG. 35A is a graph of theforce/extension curve of one embodiment of the attachment mechanism 14.FIG. 35B is a graph of the force/extension curve of the base end 16 ofone embodiment of the jacket 12. In this example of cardiac supportdevice 10, the slope of the force/extension curve of the jacket base end16 is steeper than that of the attachment mechanism 14. FIG. 35C is anillustration of the force/extension curves shown in FIGS. 35A and 35Csuperimposed on one another in a manner that represents the operationalrelationship between these curves in the cardiac support device 10. Asshown, the zero force locations of the force/extension curves are atdifferent extension locations (i.e., the curves have differentialstarting points). This characteristic represents the fact that for thisembodiment of cardiac support device 10, the attachment mechanism 14will be in a stressed (e.g., expanded) state when the jacket 12 is inits neutral (e.g., un-stressed) state. FIG. 35D is a graph of thecomposite force/extension curve of the cardiac support device 10. Themarker in FIG. 35D illustrates where the jacket 12 effectively beginscontributing to the curve. As is evident from FIGS. 35C and 35D, whilethe jacket 12 is in its neutral (and possibly collapsed) state, theforce applied by the cardiac support device 10 is all provided by theattachment mechanism 14. For an initial range of expansion of the jacket12 beyond its neutral point, the force applied by the jacket is lessthan that applied by the attachment mechanism 14, so the overall forceapplied by the cardiac support device 10 is dominated by that providedby the attachment mechanism. With continued expansion of the jacket 12,the force applied by the jacket will reach a point where it equals theforce applied by the attachment mechanism 14. When the jacket 12 isexpanded beyond the point where the force applied by the jacket 12equals the force applied by the attachment mechanism 14, the overallforce applied by the cardiac support device 10 will be dominated by thatprovided by the jacket. The relative forces applied by the attachmentmechanism 14 and jacket 12 in other embodiments of the invention can bedifferent than those shown in FIGS. 35A-35D. The relative forces appliedby the jacket and fitting structures of other embodiments of theinvention can also be similar to those illustrated in FIGS. 35A-35D.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the invention. In particular, any self-attachmentmechanisms of the invention can be combined on the same jacket with anyof the self-fitting mechanisms of the invention to produce additionalembodiments of cardiac support devices having securing mechanism inaccordance with the invention. Cardiac support devices in accordancewith the invention can be implanted on the heart using any desiredapproaches including minimally-invasive and open chest procedures.

1. A cardiac support device including: a compliant and elastic jackethaving base and apex regions and circumferentially closed between thebase and apex regions, for surrounding at least a lower portion of aheart and constraining cardiac expansion; and an elastic attachment bandon the base region of the jacket and extending circumferentially aroundthe jacket to self-attach the jacket to a heart by applying a force tothe base region of the jacket and holding the base region of the jacketon the heart.
 2. The cardiac support device of claim 1 wherein theattachment band is attached to an exterior surface of the jacket.
 3. Thecardiac support device of claim 1 wherein the attachment band isattached to an interior surface of the jacket.
 4. The cardiac supportdevice of claim 1 wherein: the jacket base region includes a hem; andthe attachment band is within the hem.
 5. The cardiac support device ofclaim 4 wherein the attachment band is fixedly attached to the jacketwithin the hem.
 6. The cardiac support device of claim 1 wherein: thejacket base region includes a channel; and the attachment band isfree-floating within a channel.
 7. The cardiac support device of claim 6wherein the jacket includes a hem forming the channel.
 8. The cardiacsupport device of claim 1 wherein: the jacket has a first elasticity;and the attachment band has a second elasticity that is greater than thefirst elasticity.
 9. The cardiac support device of claim 1 wherein: thejacket has a first elasticity; and the attachment band has a secondelasticity that is less than the first elasticity.
 10. The cardiacsupport device of claim 1 wherein the attachment band includes a polymerband.
 11. The cardiac support device of claim 1 wherein the attachmentband includes a metal structure.
 12. The cardiac support device of claim1 wherein the attachment band extends completely around the jacket. 13.The cardiac support device of claim 1 wherein the attachment bandextends partially around the jacket.
 14. The cardiac support device ofclaim 1 wherein the attachment band includes a plurality of segments atspaced-apart locations.
 15. The cardiac support device of claim 1wherein the attachment band includes a hoop having two free ends. 16.The cardiac support device of claim 1 wherein the elastomeric bandincludes apertures.
 17. The cardiac support device of claim 1 whereinthe attachment band includes a plurality of spaced-apart elastomericbands.
 18. The cardiac support device of claim 1 wherein the jacketincludes knit material.
 19. The cardiac support device of claim 1wherein the jacket has an open apex.
 20. The cardiac support device ofclaim 1 wherein the jacket has a closed apex.
 21. The cardiac supportdevice of claim 1 wherein: the jacket is formed from knit, open-cellmaterial having a channel defined by a hem on the base region; theattachment band includes a single polymer band within the channelextending at least substantially entirely around the base region of thejacket; and the device further includes an attachment structure toattach the band to the jacket.
 22. The cardiac support device of claim21 wherein the band is a solid band.
 23. The cardiac support device ofclaim 22 wherein the jacket has an open apex.
 24. The cardiac supportdevice of claim 23 wherein the attachment structure to attach the bandto the jacket includes a stitch between the band and the jacket.